TAIZ -Monocytes for the Induction of Donor Specific Tolerance in Renal Allograft Recipients (Cadaver Kidney)

Exclusion Criteria

• •1. Patients who have received a renal transplant.
• •2. Patients who have an active infection at the time of entry into the study (Screening).
• •3. Recipient and donor pairs who show the following incompatible CMV constellation: the donor is CMV positive and the recipient is CMV negative.
• •4. Patients and donor who have positive evidence of HIV or have active virus hepatitis B and C.
• •5. Patients with a history of alcohol and/or drug abuse.
• •6. Patients who are pregnant women or nursing mothers.
• •7. Known hypersensitivity or contraindication to one of the immunosuppressives administered during the course of the study: tacrolimus, sirolimus or steroids (prednisolone and methylprednisolone).
• •8. Patients with a history or present symptoms of autoimmune vasculitis.
• •9. Detection of \>5% HLA antibodies (current values determined during the last three months).
• •10. Patients with a malignancy or history of malignancy.
• •11. Patients with renal insufficiency due to a vasculitis.
• •12. Recipient and donor pairs with complete HLA matching.
• •13. Patients whose condition requires continuous systemic steroid administration.
• •14. Patients who are simultaneously participating or plan to participate in any other clinical study.
• •15. Psychiatric or emotional problems or lack of knowledge of the German language which would invalidate the giving of Informed Consent or limit the ability of the subject to comply with study requirements.
• •16. Unwillingness or inability to provide Informed Consent or to participate satisfactorily for the entire trial period